Overview In this role you drive global regulatory strategies and submissions for medical devices, including AI-enabled software and ultrasound technologies. You will lead a regulatory team, partner with Clinical and Global Regulatory Affairs, and ensure timely approvals across USA, EU, China, and other markets. You'll interpret requirements, manage dossiers, and liaise with authorities to support market access and ongoing compliance. This position offers the chance to shape regulatory programs, influence cross-functional decisions, and advance innovative medical devices at scale.
Responsibilities- Lead global regulatory strategies for new registrations, software updates, and product lifecycle management across key markets (FDA, EU MDR, NMPA)
- Oversee preparation and submission of technical documentation and regulatory dossiers to authorities (FDA, NMPA, EU bodies)
- Coach and manage a team of regulatory professionals to meet strategic and operational goals
- Interpret regulatory requirements for medical devices (IEC/ISO, NMPA, FDA 510(k), MDR) and define submission plans
- Act as liaison to regulatory authorities and stakeholders; manage review interactions and responses
- Monitor international regulatory changes and communicate impacts to cross-functional teams
- Represent the company in industry groups or regulatory associations
- Support training and knowledge-sharing on country-specific regulatory requirements
Key requirements- BS/MS degree or equivalent experience
- Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR
- Superior presentation and communication skills with all levels of the organization
- Ability to work with evolving technologies, systems, and global teams in a fast-paced environment
- Knowledge of EAR, ITAR, and OFAC sanctions regulations
- strong communication
- cross-functional collaboration
- leadership
- global medical device regulatory expertise (FDA 510(k), EU MDR, NMPA)
- technical documentation and regulatory dossiers
- submissions management
